With 2026 underway, signs point to another year focused on enhancing health IT and digital health innovation. From new payment models to deregulatory efforts, these developments show that digital health continues to be increasingly central to the healthcare and life sciences sectors. Below are five key developments to watch unfold in the year ahead.
- Reducing Barriers to AI Adoption in Clinical Care
On December 19, 2025, the Department of Health and Human Services (“HHS”) issued a request for information (“RFI”) on how HHS can “accelerate the adoption and use of AI as part of clinical care.” The RFI seeks feedback on (1) how current regulations impact AI adoption and use for clinical care; (2) payment policy changes that promote access, competition, and affordability for AI tools for clinical care; and (3) ways in which HHS can invest in research & development to integrate AI in care delivery. Importantly, certain questions solicit input on “non-medical device” AI tools for clinical care, including with respect to novel legal and implementation issues and AI evaluation methods, and how HHS can support or help to address these issues.
Comments may be submitted through February 23, 2026, and companies should consider submitting feedback as part of this important effort to shape future federal AI policies.
- Incentivizing Technology Adoption to Improve Chronic Care
The Centers for Medicare & Medicaid Services (“CMS”) and the Food and Drug Administration (“FDA”) recently announced programs aimed at encouraging adoption of digital health tools in chronic care management. Starting July 2026, the CMS Innovation Center will roll out its ACCESS Model (“Advancing Chronic Care with Effective, Scalable Solutions”), a voluntary, ten-year payment model that incentivizes use of technology to manage chronic conditions. Under the ACCESS Model, Medicare Part B providers will be rewarded with recurring payments for using technology-enabled services to improve patient outcomes and coordinate care. The model will focus initially on four clinical tracks: early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health conditions.
Alongside ACCESS, FDA’s device center launched its TEMPO Pilot (“Technology-Enabled Meaningful Patient Outcomes”). TEMPO is a voluntary program through which device manufacturers can request that FDA exercise “enforcement discretion” (i.e., not actively enforce device requirements, including premarket review) for digital health devices that are intended for patient care covered by the ACCESS Model. FDA expects that manufacturers participating in the pilot will collect real-world data about use of the device, share this data with FDA, and ultimately seek marketing authorization from the Agency. While the TEMPO Pilot is focused on a particular scope of products, it indicates new FDA thinking to help reduce regulatory friction for manufacturers developing novel digital health devices in certain clinical use cases. FDA is collecting statements of interest for participation in the TEMPO Pilot.
- FDA’s Evolving AI and Software Policies
In addition to the TEMPO Pilot, FDA continues to focus on adapting its regulatory policy to the proliferation of software and AI tools for health and wellness. To kick off the year, the Agency released revised versions of its General Wellness Policy for Low Risk Devices (“General Wellness Policy”) and Clinical Decision Support Software (“CDS”) Guidance. The revisions to the General Wellness Policy focus on sensor-based technologies, such as wearables, that measure physiological parameters. The revisions to the CDS Guidance offered more nuanced clarity regarding when CDS can offer singular recommendations without being subject to active device regulation. See our client alerts on the revised policies here (General Wellness Policy) and here (CDS Guidance) for more.
We also continue to watch FDA’s approach to use of generative AI in health care, coming off a year where FDA held its second Digital Health Advisory Committee (“DHAC”) meeting focused on genAI. The full extent to which the Trump Administration’s deregulatory, pro-innovation stance will translate into concrete FDA regulatory policies remains to be seen. FDA’s device center is expected to revise its Policy for Device Software Functions and Mobile Medical Applications this year, so we will be monitoring to see whether the Agency uses this guidance as a vehicle to more squarely discuss genAI tools or implement any of the recommendations from the DHAC, as well as the feedback received in response to the request for public comment on real-world evaluation of AI-enabled devices.
- Increasing Interoperability and Data Sharing, with an Emphasis on APIs
On December 22, 2025, HHS, through the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”), released the HTI-5 Proposed Rule. Among other proposals, HTI-5 proposes withdrawing or revising more than half of the existing technical and interoperability requirements for certified EHR technology as part of the Health IT Certification Program and updating ASTP/ONC’s information blocking regulations. The proposal aims to streamline certification by reducing prescriptive EHR functionality requirements in favor of API-focused certification, with the goal of enabling greater interoperability, improving patient access to electronic health information, and unlocking innovation by third-party AI-enabled apps.[1] The HTI-5 Proposed Rule will be available for public comment through February 27, 2026.
The emphasis on the use of APIs to improve the electronic exchange of health information aligns with CMS’s Interoperability and Prior Authorization Final Rule (CMS‑0057‑F), which begins driving payer-side API obligations in 2026 with the goal of improving patient, provider, and payer access to interoperable patient data and reducing the burden of prior authorization processes, and TEFCA (the “Trusted Exchange Framework and Common Agreement”), which is expected to play an increasing role in 2026 in efforts to promote nationwide data sharing.
The HTI-5 Proposed Rule is in early stages, but if advanced alongside the implementation of CMS’s Final Rule and the growth of TEFCA, the proposal could expand opportunities for app developers to integrate directly with EHRs.
- Advancing the CMS Health Technology Ecosystem Initiative
As we previously discussed, the CMS Health Technology Ecosystem initiative, launched in July 2025, sets out goals to modernize the digital health ecosystem, including through improvements to data exchange within healthcare. 2026 will be a pivotal year for the initiative, with more than 60 companies pledging to collaborate with CMS in Q1 on patient-centric data sharing and innovative patient-facing health apps. In line with these strategic objectives, CMS has announced plans to add a consumer app library to Medicare.gov to “highlight trusted, personalized digital health tools focused on prevention, chronic disease management, and cost-effective care navigation.” While the plan is still new, it is possible that inclusion in the library may increase an app’s visibility and credibility with Medicare beneficiaries. It is not clear whether activities in 2026 will also include a focus by Congress or HHS on the legal and regulatory regimes that govern these platforms, such as efforts to expand federal privacy protections for health information not subject to HIPAA.
[1] Note that compliance with several Health IT Certification Program requirements that were set to go into effect on January 1, 2026 is subject to enforcement discretion through March 1, 2026, due to the government shutdown.